The primary objective of this pilot study is to investigate the feasibility of an intervention based on the Arm Activity Tracker that aims to increase arm use during daily life conditions in stroke patients. Secondary objective is to obtain…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
CVA / beroerte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is feasibility of the intervention based on the Arm
Activity Tracker. The following feasibility parameters will be evaluated: 1)
technical and operational feasibility of the device, 2) user acceptance, 3)
adherence during the intervention.
Amendment:
- We will extend the evaluation of the feasibility parameter *user acceptance*
by also determining how contextual, social and personal factors influence the
user acceptance.
Secondary outcome
Secondary study parameter is the difference in objectively measured arm use in
daily life between the intervention condition and control condition.
Amendment:
- We will extend the secondary study parameter by also investigating the
patient characteristics that have an impact on the changes observed in the
objectively measured arm use in daily life.
Background summary
People that have suffered from a stroke frequently have an impaired function of
the affected arm in daily life. Studies showed that a high intensity of arm
exercise and high levels of arm use in daily life contribute to better arm
functioning. However, currently there are no feasible and effective therapies
available for stimulating arm use in daily life outside supervised therapy
sessions. Therefore, we designed and developed an Arm Activity Tracker that
provides objective feedback to stimulate people with a stroke to use the arm
outside supervised therapy more frequently and intensively.
Study objective
The primary objective of this pilot study is to investigate the feasibility of
an intervention based on the Arm Activity Tracker that aims to increase arm use
during daily life conditions in stroke patients. Secondary objective is to
obtain preliminary estimates of the effectiveness of the intervention in
increasing arm use for planning a larger randomized controlled trial. Since the
Arm Activity Tracker has been designed and developed in a user-centered design
and development process, we hypothesize that the intervention is feasible for
application in a clinical setting.
Amendment:
To get more in-depth information, we will extend both objectives. We will
extend the primary objective by also investigating how the context, social and
personal factors influence the user interaction and use of the Arm Activity
Tracker. We will extend the secondary objective by also determining the patient
demographics for which the device is best suited.
Study design
Randomized cross-over within-subjects design with an intervention and control
condition. The order of the conditions will be balanced across participants.
Amendment:
To obtain the information for the extended aims, the control intervention is
not needed. Instead, the study will be performed as a non-controlled
explorative study.
Intervention
In the intervention condition participants will wear the system for two weeks
while receiving direct feedback on arm use from the device and coaching on
objectively measured arm use from a therapist. In the control condition
participants will wear the system (to measure arm use) for two weeks without
direct feedback from the device and without coaching on objectively measured
arm use from a therapist. Before the intervention and control condition
participants will wear the system for one week to measure baseline arm use
level.
Amendment:
For the extended aims, we will skip the control condition.
Study burden and risks
It is important that the study is performed in stroke patients since the Arm
Activity Tracker is specifically developed for people with a stroke. During the
study we will ask patients to wear the Arm Activity Tracker during daily life
activities. The activities that will be performed by the stroke patients are
normal daily activities. Patients do not need to change their usual daily
activities when participating in the study. Hence, for participants risks are
not increased and the burden for participants is minimal.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- People that suffered from an ischemic or hemorrhagic unilateral stroke more
than one week ago and less than six months ago.
- The stroke resulted in new reduced upper limb function on one side.
- Age: 18 years or older.
- Subjects have to be able to lift the paretic arm against gravity.
- Inpatient in rehabilitation institute.
- Participants have to be able to do on/off the devices on both wrists
independently or with the assistance of a caregiver.
- Participants need to be able to provide informed consent as documented by
signature.
- The patient is planned to stay in the rehabilitation institute for at
least five weeks from the start of the study
Amendment:
To evaluate the extended aims, we aim to include 12 additional participants
with same characteristics but that are:
-Getting outpatient treatment in a rehabilitation institute or planned to
received outpatient treatment in a rehabilitation institute, for at least five
weeks from the moment of inclusion.
Exclusion criteria
- Severely reduced upper limb function which results in inability to lift the
affected hand off the lap when sitting.
- Upper limb complications (e.g. frozen shoulder, severe upper limb pain).
- Participants cannot comply with the study as a result of significant
cognitive, communication or visual impairment.
- Severely impaired sensation resulting in inability to sense vibro-tactile
triggers from the arm activity tracker.
- Severely impaired vision which results in inability to read messages from the
display of the hand activity tracker.
- Comprehensive aphasia which results in inability to read and/or understand
messages from the display of the hand activity tracker.
- Potential non-compliance, such as known intolerance to the device material,
major comorbidities (e.g. cardiopulmonary disease, orthopaedic disorders of the
upper limb).
- Major depression.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71693.078.19 |